The
Clinical Protocol and Data Management Shared Resource (CPDM)
is a component of the Center’s Clinical
Trials Unit that provides central management and oversight of all
clinical trials activities of the Center.
The
Shared Resource provides a range of management and quality control
functions that are essential
for conducting clinical trials research in Hawaii’s decentralized
community practice setting. It includes a central location
for all cancer protocols, a centralized database of protocol-specific
data, an updated list of currently active protocols for the
use
of Center investigators, and status reports of protocols. It
provides a centralized organization for activating and monitoring
protocols
throughout Hawaii’s multiple community offices and medical
centers involving several Institutional Review Boards (IRBs).
Quality control functions include: insuring subject safety
and compliance
with federal requirements through the Data and Safety Monitoring
plan, insuring staff competency through training for research
nurses, CRAs, clinical trials assistants and community office,
clinic,
and hospital staff engaged in Hawaii’s cancer clinical
trials enterprise, and insuring recruitment of underserved
minorities through focused outreach activities.